维护达鲁纳维尔/里托纳维尔单疗法以预防周产期艾滋病毒传播,ANRS-MIE 168 MONOGEST研究

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Laurent Mandelbrot^1,2,3, Roland Tubiana^4,5, Pierre Frange^2,6

¹Assistance Publique-Hôpitaux de Paris Hôpital Louis Mourier Service de Gynécologie-Obstétrique, F-92700 Colombes, France.

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概括

使用达鲁纳维尔/里托纳维尔单疗的围产期NRTI缓解策略显示,艾滋病毒感染孕妇的病毒负载抑制高. 这种方法可以防止母婴艾滋病毒传播,但在某些情况下需要加强治疗.

科学领域:

产科和妇科产科和妇科
传染性疾病传染性疾病
药理学药理学是指药理学的学科.

背景情况:

在抗逆转录酶疗法 (ART) 中使用的核酸逆转录酶抑制剂 (NRTIs) 可以在怀孕期间对胎儿构成风险.
预防周产期艾滋病毒传播是母亲和儿童健康的关键目标.
需要使用替代性ART策略,以尽量减少胎儿接触潜在毒性药物.

研究的目的:

评估达鲁纳维尔/里托纳维尔单一治疗方案在艾滋病毒感染的孕妇中维持病毒负载抑制 (<50副本/毫升) 到分娩时的疗效.
评估在怀孕期间使用这种NRTI节约策略时需要加强治疗的必要性.
通过这种管理方法来确定围产期艾滋病毒传播率.

主要方法:

进行了一项多中心,单臂的2期临床试验.
在第一季度接受ART治疗的病毒载量<50副本/毫升的孕妇接受了达鲁纳维尔/里托纳维尔 (600/100毫克每天两次) 的维护单疗法.
每个月监测病毒载量,如果病毒载量超过50拷贝/毫升,则加剧ART;新生儿接受nevirapine预防药物.

主要成果:

在83名可评估患者中,90.4%至92.8%的患者在分娩期间保持病毒载量<50拷贝/毫升,这取决于缺失数据的处理方式.
六名患者经历了病毒学失败,在这些情况下ART强化.
在研究队列中没有观察到围产期艾滋病毒传播病例.

结论:

达鲁纳维尔/里托纳维尔维护单疗法有效抑制怀孕期间的病毒载量,并预防周产期艾滋病毒传播.
大约10%的患者需要加强治疗,这可能会限制这种NRTI节约策略的广泛采用.
对替代NRTI节约疗法的进一步研究是有必要的,以尽量减少怀孕期间的抗逆转录病毒暴露.

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